Shamkris Global Group

Enquire Now

USA FDA DRUG REGISTRATION

What is USA FDA Drug Registration?

To obtain product DRUG approval, a firm must submit a New Drug Application (NDA), or an Abbreviated New Drug Application (ANDA) to the FDA. For OTC drugs, direct registration and listing are possible. 

Drugs sold over the counter without prescription are called over-the-counter (OTC) drugs. OTC drugs are classified under ‘Generally Recognized as Safe and Effective (GRASE) and are exempted from pre-market approval such as ANDA or NDA.

OTC monograph details about what active ingredients may be used, at what level, and for what intended uses in the drug formulation.

Type of Operations FDA mandates Drug Establishment Registration.

  • New or pioneer drugs (NDAs),
  • Generic copies of the new pioneer drugs (ANDAs),
  • OTC drugs
  • Homeopathic drugs
  • Drug testing labs
  • Sterilization facilities etc.

Homeopathic drugs covered in HPUSP that comply with the FDA’s homeopathic drug Compliance Policy Guide (CPG) also do not require FDA approval before they are marketed. Homeopathic drugs must also be registered and listed.

Unless exempted by law, all drug manufacturers must complete the FDA Drug Establishment Registration before they can be marketed in the USA. This is applicable for Generic, Prescription, and OTC  drugs, both domestic and foreign import.

Benefits of USA FDA Drug Registration

Reduced risk

Reputation

Access to new business

Improved efficiency

Customer satisfaction

Helps you stand out from your competitors

Who can be certified USA FDA Drug Registration?

Capsule

Powder

Tablet

Liquid

Document required for USA FDA Drug Registration

  • Technical File, Product Master File (TCF)
  • Product Testing
  • System Manual
  • System Procedure
  • FDA Manufacturing License
  • WHO GMP Certificate
  • Free Sale Certificate
  • Objectives
  • Plant Master File
  • Standard Operating Procedure (SOP)
  • Checklist
  • Forms
  • Formats
  • Records
  • Mission & Vision
  • Policy

The extent of Documented Information differs as per:

  • Import Country Requirements
  • Product and it's uses
  • Composition of the product

Role of Shamkris and Process of USA FDA Drug Registration

Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives. 

The implementation process is described below:

Time Frame

Task

Process

Step 1

Identify the drug and route of approval.

  • Monograph listed items can be directly registered with the FDA, others via ANDA/NDA

Step 2

How Important is DUNS number?

  • DUNS address must match with actual address provided for FDA registration. In deviation will leads to cancellation of registration after few days.

Step 3

Appoint US Agent

  • Fill the online application form and submit online. Online Application form.

Step 4

NDC number request with FDA

  • First 5 digit of the NDC number provided by the FDA ( more details)

Step 5

SPL Preparation & Submission.

  • Prepare & Submit SPL after verification by client team

Step 6

Update SPL, NDC Number and complete FDA Drug Establishment Registration

  • Maximum time taken to complete the process is 7-14 working days.

Step 7

Complete Drug Listing

  • After Drug Establishment Registration, manufacturers must list all the drug products planning for commercial distribution in the United States of America.

Time Frame

Step 1 to Step 7

  • It takes 12 to 15 weeks to done process

FAQ

An unique identification number issued by the FDA to track inspections of the registered drug facilities. FEI numbers are also used to track GDUFA facility fee payments.

 

FEI number is not for registrants, it is for FDA’s official purpose, therefore all facilities registered with the FDA are not eligible for FEI number immediately after registration. In case if any of the registered firm need, they need to request the FDA.

Beginning June 1, 2009, FDA is accepting drug establishment registration and drug listing information electronically. FDA accepts drug establishment registration and drug listing information in XML files in SPL format.

Section 510 of the Act and 21 CFR part 207, requires establishment owner/operator in the manufacture of any formulation for use in human or veterinary drugs, to register their drug establishments and submit listing information for all drugs in commercial distribution.

Every year before December 31, the owner/operator should re-submit registration and listing information with the FDA even if no marketing activities are continued.

Drug Listing is mandatory for Generic and Prescription drugs.

Listing NOT mandatory for API, Laboratories, etc.

  1. Act as representative on behalf of the foreign facility
  2. Communicate with the FDA & Owner/Operator of the foreign facility

FDA introduced electronic self-identification of generic drug facility. All such manufacturers are thereby required to self-identify with GDUFA. Once, after the self-identification process, FDA determines the annual facility fees.

  1. Human generic drug and active pharmaceutical ingredient manufacturers
  2. Finished Dosage manufacturers
  3. Facilities involved in packaging and labeling of drugs
  4. Bioequivalence study centers